Shankar Musunuri, Ocugen CEO

Man­u­fac­tur­ing prob­lems trig­ger an­oth­er clin­i­cal hold for trou­bled Covid-19 vac­cine — lat­est in a string of road­blocks

Just days af­ter the World Health Or­ga­ni­za­tion sus­pend­ed the use of Co­v­ax­in af­ter a man­u­fac­tur­ing site failed an in­spec­tion, the FDA has fol­lowed up with a clin­i­cal hold on the Covid-19 vac­cine’s US co-de­vel­op­er.

De­tails are in short sup­ply, but the man­u­fac­tur­ing site run by Bharat Biotech in In­dia is at the cen­ter of the is­sue af­ter be­ing cit­ed for “de­fi­cien­cies.” On Tues­day morn­ing, Bharat Biotech’s part­ner Ocu­gen re­port­ed US reg­u­la­tors had placed a hold on the shot’s Phase II/III study. Bharat Biotech de­vel­oped the shot and li­censed it to Ocu­gen to co-de­vel­op it in the US and Cana­da.

At the start of April, the World Health Or­ga­ni­za­tion sus­pend­ed its sup­ply of Co­v­ax­in, known in the US as BBV-152, through the Unit­ed Na­tions, af­ter in­spec­tors took is­sue with the In­di­an man­u­fac­tur­ing fa­cil­i­ties of Bharat Biotech.

“This is a re­sult of the com­pa­ny’s de­ci­sion to vol­un­tar­i­ly im­ple­ment a tem­po­rary pause in dos­ing par­tic­i­pants of OCU-002 while it eval­u­ates state­ments made by the World Health Or­ga­ni­za­tion fol­low­ing their in­spec­tion of Bharat Biotech In­ter­na­tion­al Lim­it­ed’s man­u­fac­tur­ing fa­cil­i­ty,” Ocu­gen said in a state­ment. “We will work with the FDA to ad­dress any ques­tions.”

An in­ac­ti­vat­ed virus-based vac­cine, Co­v­ax­in has been in use in In­dia since ear­ly 2021. It’s al­so been au­tho­rized in about a dozen oth­er coun­tries — and the WHO en­dorsed it for emer­gency use late last year. Based on Phase III da­ta from In­dia, un­veiled in June, the shot was al­most 78% ef­fec­tive at pre­vent­ing dis­ease.

Ocu­gen has long planned a Phase II/III im­muno­bridg­ing and boost­er tri­al in the US in or­der to bring it state­side. But in No­vem­ber, the FDA is­sued a clin­i­cal hold on the IND, with few de­tails re­leased. That was lift­ed in Feb­ru­ary.

It al­so sub­mit­ted a re­quest to the FDA for emer­gency use in chil­dren above the age of 2 in No­vem­ber, but the re­quest was de­nied in March.

But just a few days ago, the WHO sus­pend­ed the sup­ply of Co­v­ax­in from the UN un­til “ap­pro­pri­ate ac­tions” were tak­en to ad­dress man­u­fac­tur­ing prac­tices that weren’t up to code with cur­rent GMP stan­dards. The WHO did clar­i­fy that there were no safe­ty or ef­fi­ca­cy is­sues with the vac­cine.

That an­nounce­ment fol­lowed just a day af­ter Bharat said it would scale back pro­duc­tion of the vac­cine, fol­low­ing a de­crease in de­mand that co­in­cid­ed with a re­duced num­ber of in­fec­tions and hos­pi­tal­ized pa­tients.

Bharat had al­ready turned to oth­er vac­cine mak­ers — such as an­i­mal vac­cine mak­er Hes­ter Bio­sciences — to help ramp up pro­duc­tion at the start of its ef­forts.

Ocu­gen’s stock $OCGN sank 9% on the news in No­vem­ber, but bounced back al­most 7% in pre-mar­ket trad­ing days lat­er.

Shares were trad­ing around $2.72 Tues­day morn­ing, down about $1 from about a month ago. That’s a far cry away from the high of $15.67 in which it was trad­ing be­fore the first clin­i­cal hold in No­vem­ber.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.